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Clinical Trial Summary

This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).


Clinical Trial Description

Study comparing intrasphincteric injection of AMDC-USR with placebo. Subjects unblinded after 12 months visits, but followed for 2 years. Subjects randomized to placebo could elect to receive open-label AMDC-USR after completing 12 months visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01382602
Study type Interventional
Source Cook MyoSite
Contact
Status Completed
Phase Phase 3
Start date November 4, 2011
Completion date January 29, 2017

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